Abstracts tagged "clinical trial"

Abstract Number: 1453 • ACR Convergence 2024
Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study
Ling Zhou¹, Juan Zhao¹, Lingyun Sun², Xuan Zhang³, Xiaomei Li⁴, Jiankang Hu⁵, Lijun Wu⁶, Zhenyu Jiang⁷, Min Yang⁸, Xiaoxia Wang⁹, Yongjun Mei¹⁰, Qingchun Huang¹¹, Yongtao Chen¹², Yang Li¹³, Lingli Dong¹⁴, Hui Luo¹⁵, Li Guo¹⁶, Jianguo You¹⁶, Yunpeng Zhang¹⁶, Ke Ren¹⁶ and Huji Xu¹, ¹Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ²Nanjing Drum Tower Hospital, Nanjing, China (People's Republic), ³Beijing Hospital, Beijing, China, ⁴The First Affiliated Hospital of University of Science and Technology of China, Anhui, China (People's Republic), ⁵Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, China, Pingxiang, China (People's Republic), ⁶People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (People's Republic), ⁷The First Hospital of Jilin University, Changchun, China (People's Republic), ⁸Nanfang Hospital, Guangzhou, China (People's Republic), ⁹Second Hospital of Shanxi Medical University, Taiyuan, China (People's Republic), ¹⁰The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹¹The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China (People's Republic), ¹²West China Hospital, Sichuan University, Chengdu, China (People's Republic), ¹³Guangdong Provincial People's Hospital, Guangzhou, China (People's Republic), ¹⁴Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), ¹⁵Xiangya Hospital, Central South University, Changsha, China (People's Republic), ¹⁶Kanova Biopharma, Zhejiang, China (People's Republic)
Background/Purpose: XKH004, the first recombinant anti-human IL-17A/F humanized monoclonal antibody in China (also known as XKH004), shares the same therapeutic target as Bimekizumab from UCB…
Abstract Number: 1603 • ACR Convergence 2024
Antineutrophil Cytoplasmic Autoantibody Levels in Patients in the Avacopan Phase 3 Trial
Frank B. Cortazar¹, Duvuru Geetha², Salem Almaani³, Christina Song⁴, Tomasz M. Wilmanski⁴, Alana M. Bozeman⁴, Peter Merkel⁵ and David Jayne⁶, and ADVOCATE Study Group, ¹New York Nephrology Vasculitis and Glomerular Center, Saint Peter’s Hospital-Albany, Albany, NY, ²Johns Hopkins University, Baltimore, MD, ³The Ohio State University Medical Center, Columbus, OH, ⁴Amgen Inc., Thousand Oaks, CA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶University of Cambridge, Cambridge, United Kingdom
Background/Purpose: The utility of measuring serial antineutrophil cytoplasmic autoantibody (ANCA) levels to guide treatment in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) is controversial.…
Abstract Number: 2012 • ACR Convergence 2024
Safety, Tolerability and Efficacy of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate: Primary Findings of the AGILE Open-label Trial
Orrin Troum¹, John Botson², Fang Fang³, Katie Obermeyer³, Supra Verma³ and Brian LaMoreaux⁴, ¹Providence Health Care/Doctor's of St John's (MDSJ) Santa Monica, CA, Santa Monica, CA, ²Orthopedic Physicians Alaska, Anchorage, AK, ³Amgen, Inc., Thousand Oaks, CA, ⁴Amgen, Inc., Deerfield, IL
Background/Purpose: Pegloticase, infused every 2 weeks over ≥2 hrs, lowers serum urate (SU) in patients with refractory gout. Decreasing infusion time is expected to improve…
Abstract Number: 2281 • ACR Convergence 2024
Assessment of Comparative Efficacy Between Candidate Biosimilar AVT05 and Reference Golimumab
Monica Luque¹, Kristina Zhelyazkova¹, Laxmikant Vashishta², Masna Rai³, Abid Sattar⁴, Richard Bucknall⁴, Steffen Leutz³ and FAUSTO BERTI¹, ¹Alvotech, Zürich, Switzerland, ²Alvotech, Bangalore, India, ³Alvotech, Jülich, Germany, ⁴Alvotech, London, United Kingdom
Background/Purpose: Golimumab is a safe and effective treatment for RA. Biosimilars to the reference product (RP) may make treatment more accessible. We assessed comparable efficacy…
Abstract Number: 2482 • ACR Convergence 2024
Long-Term Safety of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Pooled Results from Two Open-Label Extension Studies
Gerhard Wolff¹, Michael E Wechsler², Jared Silver³, Robert Price⁴, Rejina Verghis⁵, Peter Weller⁶, Peter Merkel⁷, Thomas Corbridge⁸ and Paneez Khoury⁹, ¹Clinical Development-Respiratory, GSK, Collegeville, ²Department of Medicine, National Jewish Health, Denver, CO, ³US Medical Affairs-Respiratory, GSK, Durham, ⁴Biostatistics, GSK, Stevenage, United Kingdom, ⁵Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, ⁶Beth Israel Deaconess Medical Center, Department of Medicine, Division of Allergy and Inflammation, Harvard Medical School, Boston, MA, ⁷Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ⁸US Value Evidence and Outcomes, GSK, Durham, NC, ⁹National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
Background/Purpose: The 52-week Phase III MIRRA trial demonstrated the safety and efficacy of anti-IL-5 mepolizumab in patients with EGPA. However, longer-term safety data are limited.…
Abstract Number: 0357 • ACR Convergence 2024
Evaluating Meaningful Within-Person Change Thresholds in PROMIS-Fatigue Scores from Three Phase 3 Clinical Trials of Sarilumab for Rheumatoid Arthritis Using Empirical Cumulative Distribution Function (eCDF) Curves
Clifton Bingham¹, Emily Molina², Amy Praestgaard³, Stefano Fiore³ and David Cella⁴, ¹Johns Hopkins University, Baltimore, MD, ²Johns Hopkins, Baltimore, MD, ³Sanofi, Bridgewater, NJ, ⁴Northwestern University, Chicago, IL
Background/Purpose: To evaluate changes over time in fatigue measured by Patient Reported Outcome Measures Information System (PROMIS)-Fatigue scores in rheumatoid arthritis (RA) patients treated with…
Abstract Number: 0601 • ACR Convergence 2024
Early Improvement of Pain, Long-Term Disease Control, and Quality of Life Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib
Peter C. Taylor¹, Lihi Eder², Yael Klionsky³, Fabian Proft⁴, Thomas Iyile⁵, Erin Mancl⁶, Priscila Magalhaes Reis Nakasato⁷, Xiaolan Ye⁸, Limei Zhou⁶ and Philip Mease⁹, ¹University of Oxford, Oxford, United Kingdom, ²University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ³Division of Rheumatology, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, ⁴Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁵AbbVie Inc., hyattsville, MD, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., Randolph, NJ, ⁸AbbVie Inc., Mettawa, IL, ⁹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA

Background/Purpose: Severe musculoskeletal manifestations of PsA, particularly joint pain, can result in reduced physical function, decreased quality of life, and progressive and irreversible joint damage.1,2…
Abstract Number: 0770 • ACR Convergence 2024
Efficacy and Safety of Upadacitinib in Patients with Giant Cell Arteritis (SELECT-GCA): A Double-Blind, Randomized Controlled Phase 3 Trial
Peter Merkel¹, Sara Penn², Arathi Setty², Wolfgang Schmidt³, Andrea Rubbert-Roth⁴, Ellen Margrethe Hauge⁵, Helen Keen⁶, Tomonori Ishii⁷, Nader Khalidi⁸, Liu Meng², weihan zhao², Ivan Lagunes⁹, Ana B. Romero², Peter Wung¹⁰ and daniel blockmans¹¹, ¹Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ²AbbVie, North Chicago, IL, ³Immanuel Krankenhaus Berlin, Berlin, Germany, ⁴Cantonal Hospital St Gallen, St Gallen, Switzerland, ⁵Aarhus Universitetshospital, Aarhus, Denmark, ⁶University of Western Australia, Daglish, Western Australia, Australia, ⁷Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ⁸McMaster University, Hamilton, ON, Canada, ⁹Abbvie, Inc, North Chicago, IL, ¹⁰AbbVie Inc., North Chicago, IL, ¹¹Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, Leuven, Belgium
Background/Purpose: The objective was to assess the efficacy and safety of UPA vs placebo (PBO), in combination with a GC taper regimen, in patients with…
Abstract Number: 1184 • ACR Convergence 2024
Sustained Clinical Effects After a Single Intra-articular Injection of PCRX-201 for Moderate-to-Severe Osteoarthritis of the Knee
Stanley Cohen¹, Philip G Conaghan², Marc Hochberg³, Alan Kivitz⁴, Nino Joy⁵, Derek Jackson⁵, Masato Nakazawa⁵, Mary DiGiorgi⁵ and Jonathan Slonin⁵, ¹Metroplex Clinical Research Center, dallas, TX, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ³University of Maryland School of Medicine, Baltimore, MD, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Pacira BioSciences, Inc., Tampa, FL
Background/Purpose: Osteoarthritis of the knee (OAK) is a common and severe disease. Current treatments provide temporary pain relief, demonstrating unmet need. PCRX-201 is a high…
Abstract Number: 1457 • ACR Convergence 2024
Treat-to-Target Approaches in Early Psoriatic Arthritis: Early Secukinumab versus Standard Care – 12- and 24-Week Results from a Multicenter, Open-Label, Randomized Controlled Trial
Gonul Hazal Koc¹, Marc R. Kok², Fazira R. Kasiem³, Jolanda Luime³, Ilja Tchetverikov⁴, Kim Wilhelm - de Jong³, Lindy A. Korswagen⁵, Jessica Bijsterbosch⁶, Yvonne P. M. Goekoop-Ruiterman⁷, Paul Baudoin⁸, Petra Kok⁹, Reinhard Bos¹⁰, radboud J.e.m. Dolhain¹¹ and Marijn Vis³, ¹Erasmus MC, Rotterdam, Zuid-Holland, Netherlands, ²Maasstad Hospital, Rotterdam, Netherlands, ³Erasmus MC, Rotterdam, Netherlands, ⁴Albert Schweitzer Hospital, Dordrecht, Netherlands, ⁵Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands, ⁶Amphia Hospital, North Brabant, Netherlands, ⁷Haga Hospital, Den Haag, Netherlands, ⁸Reumazorg Zuid West Nederland, Roosendaal, Netherlands, ⁹Reinier de Graaf Gasthuis, Delft, Netherlands, ¹⁰Medical Center Leeuwarden, Leeuwarden, Netherlands, ¹¹Department of Rheumatology, Erasmus University Medical Center, Rotterdam, Netherlands
Background/Purpose: The Strategy Treatments aiming at Minimal Disease Activity in PsA (STAMP) is a one-year randomized controlled trial designed to investigate the efficacy of two…
Abstract Number: 1669 • ACR Convergence 2024
Will Investigators Enroll? A Vignette Study to Gauge Investigator Equipoise in a Trial of Surgery vs. Nonoperative Therapy in Subjects with Meniscal Tear and Persistent Pain Following Physical Therapy
Jeffrey Katz¹, Faith Selzer², Katharine Fox³, Jon Dhani³, Kyna Long³, Andrea Carland⁴, Tiffany Thavison⁴, Leslie Bisson⁴, Morgan Jones³, Katherine Krupa³ and Nomi Weiss-laxer⁵, ¹Brigham and Women's Hospital, Brookline, MA, ²Brigham and Women's Hospital, Amesbury, MA, ³Brigham and Women's Hospital, Boston, MA, ⁴University at Buffalo, Buffalo, NY, ⁵U, Buffalo, NY
Background/Purpose: Clinician investigators may be unwilling to enroll all eligible subjects into randomized controlled trials (RCTs) because they feel certain subjects would benefit more from…
Abstract Number: 2016 • ACR Convergence 2024
Treat to Target in Gout Yields Superior Outcomes Compared to Treat to Avoid Symptoms Approach (results from the Gout TrEatment Strategy Overture Trial)
Anusha Moses¹, Martijn Oude Voshaar¹, Tim L.Th. Jansen² and Mart Van De Laar¹, ¹University of Twente, Enschede, The Netherlands, Enschede, Overijssel, Netherlands, ²1VieCuri Medisch Centrum, Venlo, Netherlands
Background/Purpose: Both the European League Against Rheumatism (EULAR) and the American College for Rheumatology (ACR) state that gout can be effectively managed by reducing sUA…
Abstract Number: 2285 • ACR Convergence 2024
Safety and Tolerability of a Combination of Curcumin, Omega-3 and Vitamin-D: Results from the PASCOD Study, an RA Prevention Protocol
Halle Cochrane, Caitlin Mcfadyen, Kale Mayor, Rhonda Silva, Kristin James, Xiaobo Meng, Dylan Mackay, Hani El-Gabalawy and Liam O'Neil, University of Manitoba, Winnipeg, MB, Canada
Background/Purpose: Rheumatoid Arthritis (RA) is a progressive inflammatory autoimmune disease affecting 1% of the global population for which there is currently no cure. Recent research…
Abstract Number: 2515 • ACR Convergence 2024
Upadacitinib for Refractory Behçet’s Syndrome: A Multi-center, Prospective, Open-label, Pilot Study
Weiyi Xia¹, Jiachen Li¹, Tian Liu¹ and Yuhui Li², ¹Peking University People’s Hospital, Beijing, China, ²Peking University, BeiJing, China
Background/Purpose: The aim of this prospective cohort study is to evaluate the efficacy and safety of Janus kinase (JAK) inhibitor upadacitinib in refractory Behçet’s Syndrome…
Abstract Number: 0376 • ACR Convergence 2024
Preliminary Results of the Ondansetron Pre-medication Trial in Juvenile Idiopathic Arthritis: A Pragmatic Randomized Controlled Trial Nested in the CAPRI Registry
Gaelle Chedeville¹, Heinrike Schmeling², Jean-Philippe Proulx-Gauthier³, Michelle Batthish⁴, Jean Jacques De Bruycker⁵, Brian Feldman⁶, Roberta A Berard⁷, Roxana Bolaria⁸, Amieleena Chhabra⁹, Lily Lim¹⁰, Adam Huber¹¹, Matthew Berkowitz¹², Thomas Loughin¹² and Jaime Guzman¹³, and CAPRI Registry Investigators, ¹The Montreal Children's Hospital, Montreal, QC, Canada, ²University of Calgary, Calgary, AB, Canada, ³CHU de Quebec - Universite Laval, Quebec, QC, Canada, ⁴McMaster Children's Hospital, Hamilton, ON, Canada, ⁵UNIVERSITY OF MONTREAL, Montreal, QC, Montreal, QC, Canada, ⁶Division of Rheumatology, The Hospital for Sick Children; Departments of Pediatrics and Medicine, Faculty of Medicine; The Institute for Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada, ⁷London Health Sciences Centre, London, ON, Canada, ⁸Victoria Arthritis Center, Victoria, BC, Canada, ⁹University of British Columbia, Penticton, BC, Canada, ¹⁰University of Manitoba, Winnipeg, MB, Canada, ¹¹IWK Health Centre, Halifax, NS, Canada, ¹²Simon Fraser University, Burnaby, BC, Canada, ¹³University of British Columbia and BC Children's Hospital, Vancouver, BC, Canada
Background/Purpose: About 50% of children with Juvenile Idiopathic Arthritis (JIA) receiving methotrexate (MTX) develop MTX intolerance with severe anticipatory nausea/vomiting and avoidance behaviors. Intolerance often…

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